Pain practice : the official journal of World Institute of Pain
-
Observational Study
Prior Authorization in the Treatment of Patients with pDPN and FM.
To determine prior authorization (PA) impact on healthcare utilization, costs, and pharmacologic treatment patterns for painful diabetic peripheral neuropathy (pDPN) and fibromyalgia (FM). ⋯ There was no evidence of statistically significant differences between PA and no PA cohorts in either FM or pDPN populations for total all-cause or disease-related costs.
-
Pregabalin is a commonly used therapy currently recommended as first-line treatment for a number of neuropathic pain (NeP) conditions. Since licensure, a number of clinical trials of pregabalin in different NeP conditions have been completed from which additional data on safety and tolerability can be drawn. In this analysis, patient-level data from 31 randomized clinical trials of pregabalin in peripheral NeP sponsored by Pfizer were pooled and assessed for incidence of adverse events (AEs). ⋯ Pregabalin vs. placebo risk analysis identified 9 AEs with a risk difference, for which the lower limit of the 95% confidence interval (CI) was > 1%: dizziness (risk difference [95% CI]: (17.0 [15.4 to 18.6]), somnolence (10.8 [9.5 to 12.1]), peripheral edema (5.4 [4.3 to 6.4]), weight increase (4.7 [3.9 to 5.5]), dry mouth (2.9 [2.1 to 3.8]), constipation (2.3 [1.5 to 3.2]), blurred vision (2.2 [1.6 to 2.9]), balance disorder (2.0 [1.5 to 2.5]), and euphoric mood (1.6 [1.2 to 2.0]). The most common AEs, dizziness and somnolence, typically emerged within the first 1 to 2 weeks of treatment and resolved 1 to 2 weeks later, without resulting in cessation of treatment. The data from this review provide information, indicating which AEs may be expected in patients treated with pregabalin, and suggest that careful dose titration to the highest tolerable dose is the most appropriate approach in clinical practice.
-
Randomized Controlled Trial
Effects of Topical Diclofenac Plus Heparin (Dhep+H Plaster) on Somatic Pain Sensitivity in Healthy Subjects With a Latent Algogenic Condition of the Lower Limb.
To evaluate whether a diclofenac epolamine + heparin topical (plaster) is more effective than diclofenac plaster alone in reducing deep somatic hyperalgesia in subjects without spontaneous pain and whether the effect is linked to or independent of the anti-edematous action of heparin. ⋯ Topical diclofenac+heparin is significantly more effective than diclofenac alone in reducing muscle hyperalgesia in subjects without spontaneous pain, independently of the anti-edematous action of heparin. The results provide a rationale for the use of diclofenac+heparin also in algogenic conditions without evident signs of injury/edema/hematoma.
-
Lumbar spinal stenosis (LSS) functionally impacts significant numbers of Americans per year. Current estimates place the number of Americans suffering from senescent lumbar spinal stenosis at 400,000. The prevalence of this disorder in patients ranging from 60 to 69 years of age is very high. ⋯ LSS is becoming very common and will be a major healthcare issue as the population ages. Although LSS is not life threatening, it can cause substantial disability with limitations to performing daily activities, and thus, the associated negative impact on quality of life (QOL). This article reviews the pathophysiology and current treatment options for LSS, focusing on evidence-based treatment options.
-
Randomized Controlled Trial
Subcutaneous Injection of Diclofenac for the Treatment of Pain Following Minor Orthopedic Surgery (DIRECT study): A Randomized Trial.
Parenteral diclofenac is frequently used for analgesia following minor orthopedic interventions. Currently available diclofenac formulations are for intramuscular (IM) or intravenous injection. A new 1 mL volume formulation of diclofenac containing hydroxypropyl-β-cyclodextrin (HPβCD) allows both SC and IM administration. The objective of this open-label, randomized, parallel group, active-controlled study was to assess the safety and efficacy of 75 mg diclofenac HPβCD, administered SC or IM, compared with IM Voltaren® 75 mg in inpatients undergoing minor orthopedic surgeries with moderate-to-severe postoperative pain. ⋯ Overall, the study results indicate that safety and efficacy were similar irrespective of the diclofenac formulation used; thus, the new SC diclofenac HPβCD has an acceptable tolerability profile and may be considered a valid alternative to IM-delivered diclofenac formulations.